Neoplasms

Eye Diseases

All Conditions

Eye Neoplasms

Strip of umbilical cord lining membrane allograft wrapped around the bioceramic enucleation implant. The assembly is placed inside the void orbital cavity and the muscles are sutured to the SclerFIX strips.

Chemically-treated, viro-inactivated, freeze-dried and irradiated umbilical cord lining membrane allograft used as substitute for scleral graft in support of intraocular implant.

SclerFIX

The purpose of this open, monocenter pilot trial is to evaluate the tolerance of the SclerFIX product, an allograft of umbilical cord lining membrane, in the reinforcement of ocular implants in patients who underwent enucleation due to an eye malignant tumor resection.

As scleral graft is forbidden in France, it cannot be used for support of enucleation implants. This study investigational product, SclerFIX, was developed to substitute scleral grafts in those cases.

Use of an Allograft Set-up (SclerFIX) as Replacement of Sclera Graft for Support of Enucleation Implant

Evaluation of Safety and Efficacy of Wrapping Orbital Implant by SclerFIX Product After Eye Enucleation

Evaluation of SclerFIX tolerance by physical examination of the patient: clean scar; absence of redness, edema, ulcer, granuloma and cystic lesion; absence of signs of protrusion and inflammation

Evaluation by physical examination by the surgeon of the set-up assembly and its maintenance over time with insertion of oculomotor muscles, integration of these latter, and maintenance of the movement of the implant

Surgeon assessment on completeness and difficulty of oculomotor muscles insertion at the time of product implantation (Day 0)

TBF Genie Tissulaire

Patch of umbilical cord lining membrane sutured on top of the scleral defect.

Chemically-treated, viro-inactivated, freeze-dried and irradiated umbilical cord lining membrane allograft used as substitute for scleral graft in reinforcement of scleral thinning.

Laurence BARNOUIN, MD

Justine BOSC, MSc

Thibaud Mathis, MD

Sacha NAHON-ESTEVE, MD

Jean-Pierre CAUJOLLE, MD

Célia MASCHI, MD

The purpose of this open, multicenter phase II trial is to confirm the tolerance and evaluate the efficacy of the SclerFIX product, an allograft of umbilical cord lining membrane, in reinforcement of scleral thinning in patients who underwent eye tumor exeresis.

As scleral graft is forbidden in France, it cannot be used to reinforce the sclera. This study investigational product, SclerFIX, was developed to substitute scleral grafts.

Evaluation of SclerFIX Graft in Scleral Thinning After Exeresis of Tumors of the Ocular Surface

Phase II Study: Evaluation of SclerFIX Graft in Scleral Thinning After Exeresis of Tumors of the Ocular Surface

The graft will be considered successful at 3 months if the curvature of the eye is respected without thinning, i.e., in the absence of edema, ulceration and loss of substance (thickness of the grafted area/thickness of the adjacent surface \> 80%). The scleral thickness will be determined from images obtained by optical coherence tomography (OCT).

Composite score evaluating the presence of local reactions (edema, redness, vascularization, discharge) and of ulceration, pain and foreign body sensation (0: excellent local tolerance, 46: worst possible local tolerance)

Scoring of blurred and poor vision (0: never, 4: all the time)

Measure of eye pressure using a tonometer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Use of an Allograft Set-up (SclerFIX) as Replacement of Sclera Graft for Support of Enucleation Implant	NCT05236049	Enucleated; Eye Eye Cancer	SclerFIX	45 Years - 85 Years	TBF Genie Tissulaire
Evaluation of SclerFIX Graft in Scleral Thinning After Exeresis of Tumors of the Ocular Surface	NCT05302609	Scleral Thinnin...	SclerFIX	18 Years - 80 Years	TBF Genie Tissulaire
Use of an Allograft Set-up (SclerFIX) as Replacement of Sclera Graft for Support of Enucleation Implant	NCT05236049	Enucleated; Eye Eye Cancer	SclerFIX	45 Years - 85 Years	TBF Genie Tissulaire

Spots Global Cancer Trial Database for sclerfix

Every month we try and update this database with for sclerfix cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sclerfix

Every month we try and update this database with for sclerfix cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sclerfix cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.